Weaning Invasive Mechanical VentilationNCT07455214
Multidimensional Correlation Analysis of Heart Rate Variability and Weaning Assessment Parameters in Critically Mechanically Ventilated Patients
An observational study of Weaning Invasive Mechanical Ventilation, run by Fu Jen Catholic University Hospital at 1 site in Taiwan.
Trial summary
Background： Conventional weaning assessments are widely used but often affected by factors such as poor patient cooperation, neuromuscular issues, or unstable consciousness, leading to uncertainty in extubation timing. Studies have shown that HRV differs significantly between successful and failed extubation cases. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Weaning Invasive Mechanical Ventilation
- What is being tested?
- BEATINFO ECG Sensor
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 9 Dec 2025to 31 Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will recruit participants from the Intensive Care Unit (ICU) of Fu Jen Catholic University Hospital, including the Medical Intensive Care Unit, Surgical Intensive Care Unit, and Respiratory Care Center.
Who may be able to join
- Age between 18 and 85 years.
- Received mechanical ventilation for more than 24 hours and clinically assessed as ready for a Spontaneous Breathing Trial (SBT).
- Stable ECG signal quality before extubation, meeting the basic requirements for HRV analysis.
- Obtained informed consent from the patient or their legal representative, and agreed to participate in this study and cooperate with the 72-hour follow-up after extubation.
Who cannot join
- Individuals with permanent pacemakers, defibrillators, or other devices that affect monitoring data.
- Individuals on continuous deep sedation (RAS ≤ -4) and unable to regain consciousness in the short term.
- Individuals with severe arrhythmias or unstable cardiovascular conditions that prevent reliable HRV analysis.
- Individuals with cognitive impairment or mental illness that prevents them from cooperating with the research process, or individuals deemed unsuitable for participation in this study by their clinicians.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Fu Jen Catholic University Hospital
New Taipei City
Chi-Wei Tseng, +886905301759, kiwitseng724@gmail.com
About this study
Background： Conventional weaning assessments are widely used but often affected by factors such as poor patient cooperation, neuromuscular issues, or unstable consciousness, leading to uncertainty in extubation timing. Studies have shown that HRV differs significantly between successful and failed extubation cases. However, most research features small sample sizes, focuses on single HRV indicators, and lacks integration with traditional assessments, limiting HRV's clinical application.
Effect： The study aims to develop a predictive model combining HRV and traditional weaning indicators to provide a more objective and sensitive physiological reference for ventilator weaning decisions in critical care settings.
- Conditions
- Weaning Invasive Mechanical Ventilation
- Being tested
- BEATINFO ECG Sensor
- Keywords
- Heart rate variability, BEATINFO ECG Sensor, Weaning assessment parameters
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BEATINFO ECG SensorDevice
This study will analyze changes in HRV time and frequency domain parameters during SBT, extubation, and post-extubation to evaluate their predictive value for weaning outcomes.
What is being measured
The primary outcome is the main question the study is designed to answer.
ventilator-free days(VFDs)
Perform the extubation procedure based on clinical judgment, and record the extubation process and its success or failure in detail (successful extubation is defined as not requiring reintubation within 24 hours after extubation; and the condition should be continuously monitored for up to 72 hours after extubation). Simultaneously record the clinical outcomes after extubation, including the occurrence of VAP, ICU stay days, total hospital stay, and reintubation rate.
Measured: up to 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start9 Dec 2025
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weaning Invasive Mechanical VentilationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fu Jen Catholic University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07455214
- Sponsor's protocol ID
- FJUH114476
- Status last verified
- Feb 2026
- First submitted
- 2 Mar 2026
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multidimensional Correlation Analysis of Heart Rate Variability and Weaning Assessment Parameters in Critically Mechanically Ventilated Patients
- ClinicalTrials.gov ID
- NCT07455214
- Acronym / sponsor ID
- FJUH114476
- Conditions
- Weaning Invasive Mechanical Ventilation
- Keywords
- Heart rate variability, BEATINFO ECG Sensor, Weaning assessment parameters
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fu Jen Catholic University HospitalUniversity, hospital or other
- Study start
- 9 Dec 2025 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 6 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background： Conventional weaning assessments are widely used but often affected by factors such as poor patient cooperation, neuromuscular issues, or unstable consciousness, leading to uncertainty in extubation timing. Studies have shown that HRV differs significantly between successful and failed extubation cases. However, most research features small sample sizes, focuses on single HRV indicators, and lacks integration with traditional assessments, limiting HRV's clinical application.
Effect： The study aims to develop a predictive model combining HRV and traditional weaning indicators to provide a more objective and sensitive physiological reference for ventilator weaning decisions in critical care settings.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will recruit participants from the Intensive Care Unit (ICU) of Fu Jen Catholic University Hospital, including the Medical Intensive Care Unit, Surgical Intensive Care Unit, and Respiratory Care Center.
Key inclusion criteria (4 listed)
- Age between 18 and 85 years.
- Received mechanical ventilation for more than 24 hours and clinically assessed as ready for a Spontaneous Breathing Trial (SBT).
- Stable ECG signal quality before extubation, meeting the basic requirements for HRV analysis.
- Obtained informed consent from the patient or their legal representative, and agreed to participate in this study and cooperate with the 72-hour follow-up after extubation.
Key exclusion criteria (4 listed)
- Individuals with permanent pacemakers, defibrillators, or other devices that affect monitoring data.
- Individuals on continuous deep sedation (RAS ≤ -4) and unable to regain consciousness in the short term.
- Individuals with severe arrhythmias or unstable cardiovascular conditions that prevent reliable HRV analysis.
- Individuals with cognitive impairment or mental illness that prevents them from cooperating with the research process, or individuals deemed unsuitable for participation in this study by their clinicians.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BEATINFO ECG SensorThis study will analyze changes in HRV time and frequency domain parameters during SBT, extubation, and post-extubation to evaluate their predictive value for weaning outcomes. | Device | – |
Primary outcome
ventilator-free days(VFDs)
Time frame: up to 3 days
Perform the extubation procedure based on clinical judgment, and record the extubation process and its success or failure in detail (successful extubation is defined as not requiring reintubation within 24 hours after extubation; and the condition should be continuously monitored for up to 72 hours after extubation). Simultaneously record the clinical outcomes after extubation, including the occurrence of VAP, ICU stay days, total hospital stay, and reintubation rate.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
Related trials for Weaning Invasive Mechanical Ventilation
Recruiting
Physiological Effect High-flow Tracheal Oxygen on Viscosity of Airway Mucus and Respiratory Effort in Patients Weaning From Invasive Mechanical Ventilation
Weaning From Mechanical Ventilation, Tracheostomy Weaning
RecruitingObservational study
Dynamic Non-invasive Monitoring of Inspiratory Effort
Respiratory Mechanics, Monitoring, Physiologic
Not yet recruitingObservational study
Diaphragm Hibernation and Its Driving Factors in Mechanically Ventilated ICU Patients
Diaphragm Dysfunction, Weaning Invasive Mechanical Ventilation
Not yet recruitingObservational study
Analysis of Weaning of Analgosedation and Kinetics of Emergence in Critically Ill Patients
Critical Illness, Mechanical Ventilation
Recruiting
Ultrasound Evaluation of Cardiac Function During Spontaneous Breathing Trials
Weaning Invasive Mechanical Ventilation, Weaning-induced Pulmonary Edema
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Weaning Invasive Mechanical Ventilation, run by Fu Jen Catholic University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chi-Wei Tseng (+886960-756-606 ext. 28754, kiwitseng724@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ventilator-free days(VFDs) (time frame: up to 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.